EMA agrees to review Sanofi's filing for dual SGLT-1/2 inhibitor sotagliflozin in type 1 diabetes

Sanofi announced Thursday that the European Medicines Agency (EMA) has accepted to review its marketing application for the experimental oral drug sotagliflozin, for use as an addition to insulin therapy to improve glycaemic control in adults with type 1 diabetes. Jorge Insuasty, global head of development at Sanofi, noted that sotagliflozin, which was developed in partnership with Lexicon Pharmaceuticals, "is the first SGLT-1/2 dual inhibitor to be accepted for regulatory review in Europe." 

Sanofi, which also recently submitted the drug for US approval in the same indication, said the EMA filing was supported by data from three Phase III studies involving a total of about 3000 adults with inadequately controlled type 1 diabetes. Results from the inTandem1 trial showed that sotagliflozin was associated with significant reductions in A1C levels versus placebo. The therapy also met the primary endpoint of the inTandem3 study, demonstrating superiority over placebo in the proportion of patients with glycosylated A1C less than 7 percent at 24 weeks, with no episodes of severe hypoglycaemia or diabetic ketoacidosis. 

Last December, Sanofi identified sotagliflozin as one of nine regulatory submissions it planned to make over the next 18 months.

Register as Visitor to CPhI China 2018!